Fracture fixation plate, system and methods of use

ABSTRACT

A plate for fracture fixation, a system and methods are provided including a plurality of individually adjustable heads and various features and accessories to achieve: a.) superior fixation of the plate to osteoporotic diaphyseal bone; b.) improved visualization of the fracture line; c.) intraoperative adjustability to achieve better contact of the plate and the bone; d.) reduced risk of post-surgery tendon rupture; d.) improved fixation of small volar marginal fragments; e.) improved targeting and fixing of particular fractured bone fragments and, f.) reduced surgical operation time.

CLAIM OF PRIORITY

This application is being filed as a non-provisional patent applicationunder 35 U.S.C. §111(b) and 37 CFR §1.53(c). This application is acontinuation-in-part of application Ser. No. 13/366,886 filed on Feb. 6,2012 and claims priority under 35 U.S.C. §111(e) to U.S. provisionalpatent application Ser. No. 61/531,485 filed on Sep. 6, 2011; Ser. No.61/536,316 filed on Sep. 19, 2011 and Ser. No. 61/595,986 filed on. Feb.7, 2012, the contents of which are incorporated herein by reference.

FIELD OF INVENTION

The invention relates generally to the fixation of bone fractures and inparticular to plates for the volar fixation of fractures of the distalradius.

BACKGROUND OF THE INVENTION

Fracture fixation plates for the distal radius are known in the art. Inparticular, volar fracture fixation plates for the treatment of theColles' fracture are frequently used. While many existing volar platesare effective, in many instances they do not provide the means for: a.)good visualization of the fracture; b.) achieving good contact betweenthe plate and the bone; c.) the need to target particular bonefragments; d.) the fixation of small volar marginal fragments and e.)accommodating for conditions such as morbidity of the patient in theform of osteoporotic diaphyseal bone. Furthermore, in a small butsignificant number of cases, known fracture fixation plates and/or thefasteners attached thereto can impinge upon flexor and/or extensortendons, resulting in post-operative tendon injury or rupture.

SUMMARY OF THE INVENTION

It is among the objects of this invention to overcome the limitations ofthe heretofore-known devices by providing inventive features to achieve:a.) superior fixation of the plate to osteoporotic diaphyseal bone; b.)improved visualization of the fracture line; c.) intraoperativeadjustability to achieve better contact of the plate and the bone; d.)reduction of the risk of post-surgery flexor and extensor tendonrupture; e.) improved fixation of small volar marginal fragments; f.)improved targeting and fixation of particular fractured bone fragmentsand g.) reduction of the time required to perform a surgical procedureto install a volar plate.

Although the invention is illustrated and described herein as embodiedin a volar fracture fixation plate for the distal radius it isnevertheless not intended to be limited to only the details shown, sincevarious modifications and structural changes may be made therein withoutdeparting from the spirit of the invention and within the scope andrange of equivalents of the claims.

The construction of the invention, however; together with additionalobjects and advantages thereof will be best understood from thefollowing description of the specific disclosed embodiments when read inconnection with the accompanying drawings.

For purpose of the descriptions of the invention that follow, “bottom”refers to the bone contacting surface of a plate and “top” refers to theopposite surface.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top view of a fracture fixation plate in accordance with thepresent invention.

FIG. 2 is a bottom view of a fracture fixation plate in accordance withthe present invention.

FIG. 3 is an additional top view of the fracture fixation plate of FIG.1 showing additional features of the present invention.

FIG. 4 is an additional bottom view of the fracture fixation plate ofFIG. 2 showing additional features of the present invention.

FIG. 5 is a top orthogonal view of a fracture fixation plate inaccordance with the present invention illustrating the skew axes definedby holes in the ulnar head portion of the fracture fixation plate.

FIG. 6 is top orthogonal view of a fracture fixation plate in accordancewith the present invention illustrating the skew axes defined by holesin the radial head portion of the fracture fixation plate.

FIG. 7 is a top orthogonal view of an alternate embodiment of a fracturefixation plate in accordance with the present invention illustrating theskew axes defined by holes in the ulnar head portion of the fracturefixation plate.

FIG. 8 is top orthogonal view of an alternate embodiment of a fracturefixation plate in accordance with the present invention illustrating theskew axes defined by holes in the radial head portion of the fracturefixation plate.

FIG. 9A is a top view (semi-transparent for clarity) of a fracturefixation plate in accordance with the present invention with bonefasteners and K-wires installed therein.

FIG. 9B is a longitudinal cross section of the fracture fixation platein FIG. 9A showing the ulnar side of the fracture fixation plate.

FIG. 9C is a longitudinal cross section of the fracture fixation, platein FIG. 9A showing the radial side of the fracture fixation plate.

FIG. 10A is a top view of a fracture fixation plate in accordance withan alternate embodiment of the present invention with bone fastener-sinstalled therein, and superimposed on a human radius bone to illustrateits relative positioning.

FIG. 10B is a longitudinal cross section of the fracture fixation platein FIG. 10A showing the ulnar side of the fracture fixation plate.

FIG. 10C is a longitudinal cross section of the fracture fixation platein FIG. 10A showing the radial side of the fracture fixation plate.

FIG. 11 is a bottom orthogonal view of a fracture fixation plate inaccordance with the present invention illustrating various portions ofthe bone contacting surface of the fracture fixation plate.

FIG. 12 is a bottom orthogonal view of a fracture fixation plate inaccordance with the present invention illustrating the range ofadjustability of the position of the radial head portion of the fracturefixation plate.

FIG. 13 is a perspective view of an alternate embodiment of a fracturefixation plate in accordance with the present invention installed on thevolar aspect of a human radius bone illustrating its position relativeto the watershed line.

FIGS. 14A and 14B are diagrams illustrating the relative positioningbetween a flexor tendon in the volar side of the human radius bone andprior art single-headed fracture fixation plates.

FIG. 14C is a diagram illustrating the relative positioning between aflexor tendon in the volar side of the human radius bone and a fracturefixation plate in accordance with the present invention.

FIGS. 15A and 15B show, respectively, prior art threaded fastener andthe relative positioning between an extensor tendon and the prior artthreaded fastener affixed to a fracture fixation plate installed on thevolar aspect of a human radius bone.

FIGS. 15C and 15D show, respectively, a threaded fastener in accordancewith the present invention and the relative positioning between anextensor tendon and a threaded fastener in accordance with the presentinvention affixed to a fracture fixation plate installed on the volaraspect of a human radius bone.

FIG. 16A is a perspective view of a variable angle cannulated fastenerin accordance with the present invention.

FIG. 16B is a longitudinal, perspective cross-section view of variableangle cannulated fastener in accordance with the present invention.

FIGS. 17A-17I illustrate the procedure for installing a variable anglecannulated fastener of FIGS. 16A-16B

FIG. 18A is a partial top orthogonal view of an alternate embodiment ofa fracture fixation plate in accordance with the present inventionillustrating suture holes and a communicating channel therebetween.

FIG. 18B is a bottom orthogonal view of the fracture fixation plate inFIG. 18A.

FIGS. 19A-19E illustrate a hook plate for use in conjunction with afracture fixation plate in accordance with the present invention tosecure a volar marginal fragment.

FIGS. 19F-19I illustrate a second embodiment of a hook plate for use inconjunction with a fracture fixation plate in accordance with thepresent invention to secure a volar marginal fragment.

FIGS. 20A-20B illustrate a fracture fixation plate in accordance withthe present invention with pre-installed head drill guides, body drillguides, K-wire aiming guides, and K-wires.

FIGS. 21A-21D illustrate the assembly of head drill guides, body drillguides, K-wire aiming guides, and K-wires relative to a fracturefixation plate in accordance with the present invention.

FIGS. 22A-22E illustrate a head drill guide in accordance with thepresent invention.

FIGS. 23A-23E illustrate a K-wire aiming guide in accordance with thepresent invention.

FIGS. 24A-24B illustrate the assembly of alternative embodiments of ahead drill guide and a K-wire aiming guide in accordance with thepresent invention.

FIGS. 25A-25D illustrate the alternative embodiment of a K-wire aimingguide of FIGS. 24A-24B in accordance with the present invention.

FIGS. 25E-25H illustrate the alternative embodiment of a head drillguide of FIGS. 24A-24B in accordance with the present invention.

FIGS. 26A-26E illustrate a body drill guide in accordance with thepresent invention.

FIGS. 27A-27B illustrate a plate bender in accordance with the presentinvention and the method of engagement of same with a fracture fixationplate in accordance with the present invention.

FIG. 28 illustrates the use of a plate bender and a plate holder engagedin bending of a fracture fixation plate in accordance with the presentinvention.

FIGS. 29A-29D illustrate the sequence of steps for assembling a fracturefixation plate with the plate holder and the plate bender in accordancewith the present invention for the purpose to applying force to theplate bender to achieve the desired adjustment.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIGS. 1 and 2, a generally “Y” shaped volar fracturefixation plate 100 is shown having a bone contacting surface 101 and anopposite surface 102, a straight or slightly curving elongated bodyportion 110 having a proximal end and a distal end and a plurality ofindependently adjustable head portions 120, 130. The plurality of headportions are angled relative to the body portion 110 about ulnar lateralaxis u1 and radial lateral axis r1 that diverge distally at an angle αnot less than 20 degrees and not greater than 45 degrees. In oneembodiment of the present invention, for use as a volar radius fixationplate, the plurality of head portions are embodied as an ulnar headportion 120 and a radial head portion 130. Head portions 120 and 130 areindependently connected to body portion 110, respectively, by ulnar neckportion 125 and radial neck portion 135 which branch out angularly fromthe distal end of body portion 110 and are independently adjustable.Body portion 110 is intended to be anchored to the diaphysis portion ofa bone while ulnar and radial head portions 120 and 130 are adapted toanchor, respectively, the ulnar and radial metaphyseal fragments of afracture. The gap 140 formed between head portions 120 and 130 as wellas between neck portions 125 and 135 allows for good visualization ofthe fracture line and to accommodate the passage of flexor tendonswithout impingement.

The volar fracture fixation plate 100 of FIGS. 1-2 corresponds to avolar plate to be installed on the volar aspect of the right humandistal radius. A volar plate for installation on the volar aspect of theleft human distal radius (not shown) is a mirror image of volar plate100, identical in all other respects and a further embodiment of theinstant invention. It should also be understood that all volar plates ofthe instant invention referred to herein can be made for the right orthe left distal radius and in different sizes to accommodate varyinganatomies.

Referring now to FIGS. 1-4 radial head portion 130 of fracture fixationplate 100 includes a plurality of threaded holes 160. In this particularembodiment, the radial head portion 130 includes three threaded holes160. The threaded holes 160 are arranged non-linearly, e.g.: as verticesof a triangle if three holes 160 are present. In alternate embodiments,if more than three threaded holes 160 are present, the holes arearranged as vertices of a polygon. Holes 160 are intended to receivebone fasteners (i.e.: screws or pegs, solid or cannulated) havingthreaded heads that are adapted to engage the threads of holes 160 ineither: a.) a fixed angle relationship (i.e.: along the axis of a hole160) or b.) a variable angle relationship (i.e.: along an axis selectedintraoperatively by the surgeon, non-collinear with the axis of a hole160). Likewise, ulnar head portion 120 includes a plurality of holes oftype 160, similarly arranged and having similar functionality to thosein radial head portion 130.

Referring again to FIGS. 1-4, radial head portion 130 of fracturefixation plate 100 optionally includes at least one non-threaded hole161. Holes 161 are intended to receive complimentarily sized Kirschnerwires (hereinafter “K-wires”) therethrough in a pre-defined angularrelationship to the bone contacting surface 101 of head portion 130. TheK-wires (shown in FIGS. 9A, 9B and 9C) enter the plate through theopposite surface 102 and exit the fracture fixation plate through thebone contacting surface 101. Likewise, ulnar head portion 120 isoptionally provided with at least one non-threaded hole 161 havingidentical functionality to those in radial head portion 130 and mayoptionally be provided with interconnected holes 164 for receivingsutures as will be explained further below.

As further shown in FIGS. 1-4, in the present embodiment, the bodyportion 110 includes at least one anchoring hole 162, which is threadedand adapted to receive anchoring fasteners with complementarily threadedheads that engage the threads of anchoring holes 162 at a fixed anglerelationship (i.e.: collinear to the axes of anchoring holes 162). Theaxes of threaded holes 162 may optionally be skew (heretofore defined asnon-coplanar) relative to each other. Furthermore, the body portion 110may optionally include one or more non-threaded anchoring slots 163, forreceiving compression screws permitting the temporary repositioning ofthe plate relative to the underlying bone during surgery. Body portion110 may optionally include one or more holes 161 intended to receivecomplimentarily sized K-wires for temporary anchoring of the bodyportion to the bone.

Referring now to FIGS. 5-6, therein is shown one embodiment of afracture fixation plate 100 having axes a1 through a9 defined by theplurality of holes 160 and 162. The actual number of axes a1, a2 . . .aN in a particular fracture fixation plate is a function of the numberof holes 160 and 162 existing in that particular embodiment of thefracture fixation plate. Axes a1, a2 and a3 in ulnar head portion 120are skew (non-coplanar, as previously defined) relative to each otherbut exist in planes that are mutually parallel. Axes a4, a5, and a6 inradial head portion 130 are also skew relative to each other and alsoexist in planes that are mutually parallel. However, the parallel planeswhere the first set of axes (a1, a2, a3) exist are not parallel to theparallel planes where the second set of axes (a4, a5, a6) exist but,instead, the first set of parallel planes diverges distally relative tothe second set of parallel planes. This arrangement is advantageousbecause skew lines are inherent to the formation of surfaces that mimicthe shape of the articular surface of at least one bone in a joint. Axesa7, a8 and a9 in body portion 110 may optionally be skew relative toeach other. This is also advantageous since fasteners anchored alongskew axes provide better anchorage of the plate to the diaphysis ofosteoporotic bone than equivalent fasteners with parallel axes.

Referring now to FIGS. 7-8, therein is shown an alternate embodiment ofa fracture fixation plate 200 having axes b1 through b10 defined by theplurality of threaded holes 260 and 262. In this particular embodimentthe ulnar head portion 220 defines four threaded holes 260 arranged asvertices of a four-sided polygon. Axes b1, b2, b3 and b4 of the threadedholes 260 in ulnar head portion 220 are skew relative to each other butexist in planes that are parallel. Axes b5, b6 and b7 of the threadedholes 260 in radial head portion 230 are also skew relative to eachother and also exist in planes that are parallel. As in the case offracture fixation plate 100, the parallel planes where the first set ofaxes (b1, b2, b3 and b4) exist are not parallel to the parallel planeswhere the second set of axes (b5, b6 and b7) exist but, instead, thefirst set of parallel planes diverges distally relative to the secondset. As previously described in reference to body portion 110, Axes b8,b9 and b10 of threaded holes 262 in body portion 2.10 are optionallyskew relative to each other.

Referring now to FIG. 9A, therein is shown a plan view of fracturefixation plate 100 (transparent, for clarity) indicating the alignmentof axes a1, a2, a3 of ulnar head portion 120 and a4, a5 and a6 of radialhead portion 130 in an example of one embodiment of the presentinvention. FIGS. 9B and 9C, respectively, show longitudinal crosssections of fracture fixation plate 100. FIG. 9B shows the ulnar sidecross section view of the alignment of axes a1, a2 and a3 of the ulnarhead 120. FIG. 9C shows the radial side cross section view of thealignment of axes a4, a5 and a6 on radial head 130. As indicated in FIG.9B, ulnar head portion 120 and is inclined upwards at an angle β (i.e.:away from the bone contacting surface) not less than 10 degrees and notgreater than 30 degrees relative to a plane defined by the peripheraledges of the bone contacting surface of longitudinal body portion 110.Radial head portion 130 is similarly inclined.

Referring now to FIG. 10A therein is shown a perspective view of thedistal volar side of a right radius bone 300, transparent for clarity,with an alternate embodiment 200 of the fracture fixation plate of theinstant invention superimposed in the correct position on the bone 300and indicating the alignment of axes b1, b2, b3 and b4 of the threadedholes and the corresponding fasteners of the ulnar head portion 220 andaxes b5, b6 and b7 of the threaded holes and the corresponding fastenersof the radial head portion 230. FIGS. 10B and 10C are, respectively,longitudinal cross sections of fracture fixation plate 200. FIG. 10Bshows the alignment of axes b1, b2, b3 and b4 of the threaded holes andthe corresponding fasteners of ulnar head portion 220. FIG. 10C showsthe alignment of axes b5, b6 and b7 of the threaded holes and thecorresponding fasteners of radial head portion 230. The alignment of theaxes of threaded holes 260 on each of the head portions and,correspondingly, the axes of the bone fasteners installed thereupon, areskew relative to each other to advantageously provide subchondralsupport of the articular surface at the lunate fossa and scaphoid fossa.As indicated in FIG. 10B, ulnar head portion 220 and is inclined upwards(i.e.: away from the bone contacting surface) at an angle β not lessthan 10 degrees and not greater than 30 degrees relative to a planedefined by the peripheral edges of the bone contacting surface oflongitudinal body portion 210. Radial head portion 230 is similarlyinclined.

Referring now to FIG. 11 therein is shown a perspective view ofparticular portions of the bone contacting surface 101 of one embodiment100 of the fracture fixation plate of the instant invention. In theulnar head portion 120 the bone contacting surface 170 is sphericallyconcave. In the radial head portion 130 the bone contacting surface 171is substantially flat. In the body portion 110 the bone contactingsurface 172 is cylindrically concave in relation to the longitudinalaxis of the body portion 110. Alternate fracture fixation plateembodiments optionally may include similar geometrical characteristicsof the corresponding surfaces.

Referring now to FIG. 12, therein is indicated the range ofadjustability of the position of radial head portion 130 of fracturefixation plate 100: 1.) separation S between head portions 130 and 120;2.) elevation E of the head portion 130 relative to the bone surface and3.) rotation R of the head portion 130 around the longitudinal axis r1of radial neck portion 135. The range of adjustability is illustrated byway of example and is not intended to be limiting. The adjustments maybe accomplished by the use of plate bending tools, as described furtherbelow, to apply appropriate bending and/or torqueing force to radialneck portion 135. The adjustments are advantageous because theyfacilitate achieving the best contact possible between the bonecontacting surfaces of the plate 100 and the underlying bone and bonefragments. Although indicated in FIG. 12 as referring to radial headportion 130, similar positional adjustment can be accomplished on ulnarhead portion 120. Alternate embodiments of the fracture fixation plateoptionally may include similar positional adjustment features.

As previously described above, the instant invention provides a fracturefixation plate with a plurality of head portions. This is particularlyadvantageous for minimizing the risk of post-operative flexor tendonrupture. Referring to FIG. 13 therein is shown a fracture fixation plate200 correctly installed on the volar side of a distal radius bone 300just proximal of the watershed line 310, a theoretical line marking themost volar aspect of the volar margin of the distal radius. Referringnow to FIG. 14A therein is shown a diagrammatic view of the articularsurface of the distal radius, with the volar aspect on the upper side ofthe diagram, wherein is indicated the scaphoid fossa 320, the lunatefossa 330 and the inter-fossae sulcus 340 and the edge of the watershedline 310. Also shown diagrammatically is a flexor tendon 350 (forexample: the Flexor Pollicis Longus). In some patients, the inter-fossaesulcus 340 is relatively shallow at the watershed line 310 and thisallows for the correct installation of a prior-art single headedfracture fixation plate 360 (shown dotted) just beyond of the watershedline 310 without post-operative impingement with a flexor tendon 350.However, as shown in FIG. 14B, in other patients, the inter-fossaesulcus 340 is much deeper at the watershed line 310. The installation ofa prior-art single headed plate (shown dotted), even if correctlyinstalled proximal of the watershed line 310, can lead to post-operativeimpingement of said plate and a flexor tendon 350 resulting intenosynovitis or rupture of the tendon. Referring now to FIG. 14Ctherein is shown, diagrammatically in dotted line, the installedposition of a double headed fracture fixation plate of the instantinvention wherein the gap between the radial head portion 230 and theulnar head portion 220 of the plate allows for the movement of theflexor tendon 350 free of impingement with either of said heads.

In a further advantageous aspect of the instant invention, a threadedfastener is provided for the purpose of minimizing the risk of thepost-surgical extensor tendon rupture. Referring now to FIGS. 15A-15Dand in particular, FIG. 15A therein is shown a prior art threadedfastener 400 having a threaded head 401 for engaging a threaded hole 160of fracture fixation plate 100 and an opposite bone engaging threadedsharp end 402. If, as can frequently occur and shown in FIG. 15B, thesharp end 402 of the threaded fastener 400 should protrude evenminimally through the dorsal aspect of a distal radius bone 300, thesharp end 402 can injure, and even cause rupture, of extensor tendon420. As shown in FIG. 15C the instant invention provides a threadedfastener 450 having a threaded head 451 for engaging a threaded hole 160of fracture fixation plate 100 and an opposite, bone engaging, roundedend 452 that is atraumatic. As shown in FIG. 15D, should the threadedfastener 450 protrude as much as 2 mm through the dorsal aspect of theradius, the rounded end 452 of the fastener will not injure or rupturethe extensor tendon 420.

As previously discussed, threaded holes 160, 260 of a volar fracturefixation plate 100, 200 are intended to receive fasteners (i.e.: solidpegs or screws) with threaded heads adapted to engage the threads inholes 160, 260. These fasteners can be received at fixed angles, thatis, collinearly with the axes of the corresponding hole 160, 260.However, it is one object of the instant invention to provide improvedtargeting and fixing of particular fractured bone fragments and in manyinstances this is difficult to accomplish by fixed angle fasteners.Accordingly, to accomplish this purpose, alternative embodiments of thepresent invention may employ cannulated, variable angle fasteners.

Referring now to FIGS. 16A-16B therein is shown one embodiment of acannulated variable angle fastener 500 adaptable for use with thepresent invention. FIG. 16A shows a perspective view of a variable anglecannulated fastener 500, in this instance a screw, having a taperedthreaded head 501 adapted to engage a threaded hole 160, 260 at an angleselected by the surgeon. Variable angle cannulated fastener 500 mayoptionally have a threaded portion. 502 adapted to engaging a bonefragment.

FIG. 16B shows a longitudinal, perspective cross-section view ofvariable angle fastener 500 with longitudinal cannula 503 extendingthrough the entire length of variable angle fastener 500 and open atboth ends. The cannula 503 of variable angle fastener 500 is adapted tobe inserted over an appropriately sized K-wire.

As shown in FIGS. 17A-17I a cannulated variable angle fastener 500 maybe used where the fixed angle axis of a threaded hole 160, 260 in avolar plate 100 or 200 would lead to an undesired result. FIG. 17A, 17Bshow a fracture fixation plate 200 having been correctly installed onthe volar side of a distal radius bone 300 with threaded head fastener520 coaxial with the axis of threaded hole b5. In particular, as shownin FIG. 17B, with the radius bone 300 shown transparent for clarity,axis b5 of the most lateral threaded hole 260 determines that fixedangle fastener 520 inserted therethrough will be anchored into theproper position within the radius bone 300. However, on a smaller radiusbone 300′ of a different patient, as shown on FIGS. 17C and 17D, a fixedangle fastener 520 inserted following axis b5 would protrude from thebone, possibly causing injury to the surrounding soft tissue. In thissituation the surgeon may prefer to select an alternate axis, such asb5′ in FIG. 17C, not coaxial with axis b5 of threaded hole 260, throughwhich to insert a fastener.

To accomplish this, as shown on FIG. 17E, a K-wire 530 is directedthrough the threaded hole 260 and drilled into the bone or bone fragmentalong the surgeon selected axis b5′. Using a cannulated drill, (notshown) the surgeon drills over the K-wire 530 to create a cavity alignedwith the desired axis b5′. As further shown in FIGS. 17F-17G, after thecannulated drill is removed, the variable angle cannulated fastener 500is inserted over the K-wire 530 and torqued with a cannulated driver(not shown) to engage the bone fragment resulting in the correctpositioning of the variable angle fastener 500 shown in FIG. 17G.Thereafter, as shown in FIG. 17H, with the radius bone 300′ showntransparent for clarity, the K-wire 530 is removed, resulting in thecorrect installation of variable angle fastener 500 and,consequentially, fracture fixation plate 200 as shown on FIG. 17I.

Since the alternate axis b5′ selected by the surgeon is not coaxial withthe axis b5 of threaded hole 260 of fracture fixation plate 200, thetapered thread 501 of the head portion of variable angle fastener 500must be able to fixedly cross-thread into the thread of hole 260. Toaccomplish this, variable angle fastener 500 can be made of a hardermaterial than plate 200. For example, variable angle fasteners 500 maybe made of cobalt chromium while the plate 200 is made of titanium.

As previously indicated above, ulnar head portion 120 of fracturefixation plate 100 may optionally include suture holes 164. Suture holes164 are non-threaded and mutually communicating and are intended toreceive sutures for tension binding small volar marginal fragments ofbone. FIGS. 18A and 18B show in greater detail suture holes 164 in ulnarhead portion 120 of volar fracture fixation plate 100 and theircommunicating channel 165 adapted to accommodate the suture knot. Ifdesired suture holes 164 may optionally be provided in radial headportion 130 (not shown). Similar suture holes 164 may optionally beprovided in alternate embodiments, for example 200, of the fracturefixation plate of the instant invention.

In addition to, or in substitution of the suture holes 164, the instantinvention optionally provides a hook plate for securing and reducing avolar marginal fragment. Referring now to FIGS. 19A-19C therein is shownhook plate 600, intended to be affixed to ulnar head portion 220 offracture fixation plate 200 to secure a volar marginal fragment. Asshown in FIG. 19B, hook plate 600 has a plurality of hook ends 601, aslot 602, a tensioning break-off tab 603 breakable at break-away isthmus607 and indicia 608 for post-operative detection of hook plate creep.Once a volar marginal fragment is temporarily reduced by the surgeonwith a tool (not shown) to the stable portion of the radius bone, thehook plate 600 is superimposed onto the ulnar head portion 220 of aproperly installed fracture fixation plate 200 and a retaining screw 605is inserted through slot 602 and loosely threaded into threaded hole 604of ulnar head portion 220. The surgeon then engages hook ends 601 intothe volar marginal fragment and, applies tension to the hook plate 600by pulling on tensioning break-off tab 603 until the desired reductionof the volar marginal fragment is achieved. Retaining screw 605 is thentightened into threaded hole 604 and the break-off tab 603 is removed bybending at break-away isthmus 607 and discarded as shown in FIG. 19D.The position of indicia 608 is then recorded for future reference toidentify any post-operative creep. FIG. 19E shows the finished constructof hook plate 600 having reduced volar marginal fragment 620 to stableradius bone 300 while securely affixed to the properly installedfracture fixation plate 200.

FIGS. 19F-19I show an alternative embodiment of the hook plate 600′wherein the tensioning break-off tab 603 of hook plate 600 issubstituted by a tensioning port 603′. After engaging the hook ends 601′into volar marginal fragment 620′ the surgeon applies tension by pullingon the tensioning port 603′ with a tool (not shown) until the desiredreduction is achieved. Retaining screw 605′ is then tightened intothreaded hole 604 to affix the hook plate 605′ to the fracture fixationplate 200 thereby obtaining stable reduction of volar fragment 620′ asshown in FIG. 191.

In addition to being adapted to receive the retaining screw 605, 605′,the threaded hole 604 of ulnar head portion 220 can optionally beadapted to receive a K-wire therethrough in a pre-defined orientationfor temporary fixation to a portion of the radial bone. As shown inFIGS. 19A and 19F the pre-defined orientation of the axis Φ of threadedhole 604 can be, for example, the orientation that will result in thereceived K-wire being substantially parallel to a chord drawn, volar todorsal, between the edges of the anatomical articular surface of thedistal radius. Such orientation is at an angle of 98 to 104 degreesdistally in reference to a plane defined by the bone contacting surfaceof the body portion of fracture fixation plate 200.

Although described in reference to fracture fixation plate 200 the hookplates 600, 600′, retaining screws 605, 605′ and threaded hole 604 canoptionally be provided in fracture fixation plate 100 and any otherembodiment of the instant invention.

The fracture fixation plates, system and methods of the instantinvention include, in their alternative embodiments, accessories thatcan be useful to reduce the time needed by the surgeon to complete asurgical procedure. Specifically, disclosed herein are drill guides andK-wire aiming guides that can optionally be provided pre-installed onthe respective plates 100, 200, thereby obviating the necessity ofperforming a time consuming installation thereof during surgery. Thedisclosure of said accessories of the instant invention are shown inFIGS. 20A-26E.

Referring now to FIG. 20A-21D therein are shown a fracture fixationplate 200 with a plurality of pre-installed head drill guides 700, bodydrill guides 800 and K-wire aiming guides 900. Although described inreference to fracture fixation plate 200 the head drill guides 700, bodydrill guides 800 and K-wire aiming guides 900 can also be provided orpre-installed in fracture fixation plate 100 and any other embodiment ofthe fracture fixation plate of the instant invention.

Referring now to FIGS. 22A-22E therein are shown a head drill guide 700having a proximal end [FIGS. 22A,D], a cylindrical body portion [FIG.22B] and a distal end [FIGS. 22C,E]. The distal end of head drill guide700 is provided with an external thread 710 adapted to engage into anythreaded hole 260 in any of the head portions of a fracture fixationplate 200 along the axis determined by the thread of said hole 260. Thebody portion of head drill guide 700 is internally bored, said bore 720adapted to closely receive and stabilize a drill bit (not shown)inserted therethrough. The proximal end of a head drill guide 700 isprovided with an internal thread 730 adapted to engage the threadedcentral portion of a K-wire aiming guide 900 as further described belowand said proximal end is further provided with an internal recess 740adapted to receive a torque transmitting tool (for example, a hexagonal“Allen” torque transmitting tool—not shown)

Referring again to FIGS. 21A-21C and in greater detail in FIGS. 23A-23Etherein are shown K-wire aiming guides 900. Referring now to FIG. 23BK-wire aiming guides 900 are provided with a distal elongated bodyportion 910, a threaded central portion 920 and a proximal head portion930. The distal elongated body portion 910 of K-wire aiming guide 900 isadapted to be received inside the bore portion 720 of a head drill guide700. The externally threaded central portion 920 of K-wire aiming guide900 is adapted to engage the internal thread 730 of the proximal end ofa head drill guide 700. K-wire aiming guide 900 is bored throughout thedistal elongated body portion 910, the threaded central portion 920 andthe proximal head portion 930, said bore 940 adapted to closely receiveand stabilize a K-wire inserted therethrough. As shown in FIGS. 23A and23D, proximal head portion 930 is provided with an internal recess 950adapted to receive torque a torque transmitting tool (for example, asquare driver—not shown).

Referring now to FIGS. 24A-25H therein is shown an alternativeembodiment of head drill guide 700′ and aiming guide 900′ wherein areshown external thread 920′ and corresponding internal thread 920″ forpositively engaging aiming guide 900′ in head drill guide 700′ andthread 710′ for coupling head drill guide 700′ to a plate 100 or 200(not shown). During surgery, the aiming guides 900′ are removed from thehead drill guides 700′ after the K-wires they are adapted to guidethrough bore 940′ have been drilled, leaving in place the head drillguide 700′ for the further receiving a drill bit (not shown) throughbore 720′ for drilling pilot holes for the fasteners. In order to assurethat, upon removal of the aiming guides 900′, the head drill guides 700′remain in place, it is advantageous to provide aiming guide 900′ with anexternal thread 920′ that requires less resistance to torque to obtainrelease than the external threads 710′ that couple head drill guides700′ to plates 100, 200. In one particular embodiment of the instantinvention this is accomplished by providing a threads 920′, 920″ with ahigher thread angle than external thread 710′. Given the same torqueapplied to recess 950′ of the assembled aiming guides 900′ and headdrill guide 700′, the thread with the higher thread angle will releasefirst. Exemplarily, and not intending to be limiting, threads 920′, 920″can be implemented as double lead 2-56 threads while threads 710′ can beimplemented as 5-44 single lead threads.

Referring again to FIGS. 21A and 21D and in greater detail in FIGS.26A-26E therein are shown body drill guides 800. Body drill guides 800have a proximal end [FIGS. 26A and 26D], an externally cylindrical bodyportion [FIG. 26B] and a distal end [FIGS. 26C and 26E]. The distal endof a body drill guide 800 is provided with an external thread 810adapted to engage any threaded hole 262 in the body portion 210 offracture fixation plate 200 along the axis determined by the thread ofsaid hole 262. The body portion of body drill guide 800 is boredthroughout, said bore 830 having a non-circular (for example but withoutlimitation, hexalobular) cross section perpendicular to the axis of thebore with at least three flat portions 835, said flat portions adaptedto closely receive and stabilize a drill bit inserted therethrough andsaid non-circular cross-section further capable of accepting torque froma torque transmitting tool (not shown). The proximal end of a body drillguide 800 is additionally provided with an internal recess 840 adaptedto receive torque from a different torque transmitting tool (forexample, a hexagonal Allen driver—not shown) to permit removal of a bodydrill guide 800 when its drill guiding purpose has been accomplished.

As referred to above, head drill guides 700, 700′ K-wire aiming guides900, 900′ and body drill guides 800 are optionally pre-installed on thefracture fixation plate 100, 200 prior to surgery being performed. Sincethe installation of K-wires for temporary fixation and the drilling ofpilot holes for the installation of bone fasteners require, in manyprior-art plates, that the surgeon be provided with and install theappropriate guides during surgery, providing pre-installed guidesadvantageously leads to a reduction of the time required for completingthe surgery.

As previously described above in reference to FIG. 12, plate bendingtools may be provided to apply appropriate force to radial neck portion135, 235 and/or ulnar neck portion 125, 225 of fracture fixation plate100, 200 to adjust the position of radial head portion 130, 230 and/orulnar head portion 120, 220 to obtain the best contact possible betweenthe bone contacting surfaces of the plate 100, 200 and the underlyingbone and/or bone fragments. Referring now to FIG. 27A therein is shown aplate bender 1000 provided with a plurality of notches 1010, 1020adapted to engage the radial or ulnar head portions of a fracturefixation plate 100, 200 over the head drill guides 700, 700′ and anarrower notch 1030 adapted to engage the radial or ulnar head portionswhen the head drill guides 700, 700′ are not present or have beenremoved. FIG. 27B shows a plate bender 1000 wherein notch 1020 engagesthe radial head portion 230 of a fracture fixation plate 200.

Referring now to FIG. 28, therein is shown a plate bender 1000 and acomplementary plate holder 1050. Plate holder 1050 is provided andadapted to immobilize a fracture fixation plate 100, 200 after saidfixation plate has been inserted into retaining notch 1051 on either endof plate holder 1050, while force is applied to plate bender 1000. Whensaid force is applied to plate bender 1000 in a proximal to distaldirection, shown as dotted arrow E, the radial neck portion 135, 235 isdeformed, resulting in an adjustment of the elevation of radial headportion 130, 230 relative the future underlying bone surface.Conversely, when force is applied to plate bender 1000 in a lateraldirection, shown as dashed arrow R the radial neck portion 135, 235 isdeformed, resulting in an adjustment of the rotation of radial headportion 130, 230 relative to the future underlying bone surface.

FIGS. 29A-29D illustrate the steps for assembling a fracture fixationplate 100, 200 (200 shown) with the plate holder 1050 and plate bender1000 for the purpose of applying force to plate bender 1000 to achievethe desired adjustment. Referring now to FIG. 29A, the body portion ofplate 100, 200 with body drill guides 800 pre-installed is inserted inthe direction of arrow Δ into retaining notch 1051 of plate holder 1050.Once held securely in place by the plate holder 1050 as shown in FIG.29B the plate bender 1000 is inserted over a head portion of the plate100, 200 (with head drill, guides 700, 700′ pre-installed) in thedirection of arrow Δ′. Force can then be applied indistinctly in aproximal to distal direction E (shown in FIG. 29C) or a lateraldirection to accomplish the desired deformation of the correspondingneck portion 135, 235 of plate 100, 200.

Although described above in connection with a volar fracture fixationplate, accessories, system and method for volar fixation of fractures ofthe distal radius, these descriptions are not intended to be limiting,as other plates can be made in accordance with the description herein,but of different size or scale, so as to treat other fractures, asneeded. As such, although the invention is illustrated and describedherein, various modifications and structural changes may be made thereinwithout departing from the spirit of the invention and within the scopeand range of equivalents of the claims.

We claim:
 1. A fracture fixation plate comprising: a substantially rigidplate including an elongated body portion having proximal and distalends; said plate including a bone contacting surface and an oppositesurface said plate including a plurality of head portions, eachindependently connected to the distal end of said body portion by acorresponding plurality of neck portions; each of said neck portionsdefining a neck portion lateral axis therethrough extending from thedistal end of said body portion to its corresponding head portion; eachof said head portions including a plurality of threaded holes adapted toreceive bone fasteners; each of said threaded holes defining a bonefastener axis; said body portion including at least one anchoring hole;wherein the lateral angle formed between each of said neck portionlateral axes and an adjacent one of each of said neck portion lateralaxes ranges between 20 degrees and 45 degrees.
 2. The fracture fixationplate of claim 1 wherein said plurality of head portions and saidplurality of neck portions comprises two head portions and two neckportions.
 3. The fracture fixation plate of claim 2 wherein said headportions, neck portions and body portion are arranged to comprise agenerally “Y” shaped plate.
 4. The fracture fixation plate of claim 2wherein one of said head portions is adapted to anchor the ulnarmetaphyseal fragments of a fracture.
 5. The fracture fixation plate ofclaim 4 wherein the bone contacting surface of said head portion adaptedto anchor the ulnar metaphyseal fragments of a fracture is substantiallyspherically concave.
 6. The fracture fixation plate of claim 2 whereinone of said head portions is adapted to anchor the radial metaphysealfragments of a fracture.
 7. The fracture fixation plate of claim 6wherein the bone contacting surface of said head portion adapted toanchor the radial metaphyseal fragments of a fracture is substantiallyflat.
 8. The fracture fixation plate of claim 1 wherein said bonecontacting surface of said body portion is longitudinally cylindricallyconcave.
 9. The fracture fixation plate of claim 1 wherein one or moreof said head portions is independently adjustable relative to said bodyportion through deformation of the neck portion corresponding to saidhead portion.
 10. The fracture fixation plate of claim 1 wherein atleast one of said anchoring holes is threaded and defines an anchoringfastener axis.
 11. The fracture fixation plate of claim 1 furthercomprising one or more holes adapted to receive a K-wire.
 12. Thefracture fixation plate of claim 11 wherein at least one of said holesadapted to receive a K-wire is located in at least one of said pluralityof head portions.
 13. The fracture fixation plate of claim 1 furthercomprising a plurality of suture holes on one or more of said pluralityof head portions.
 14. The fracture fixation plate of claim 13 wherein atleast two of said plurality of suture holes communicate through a suturehole communicating channel extending between said suture holes on saidopposite surface.
 15. The fracture fixation plate of claim 2 whereinsaid two neck portions and two head portions define a gap therebetweenadapted to accommodate and avoid impingement of a tendon.
 16. Thefracture fixation plate of claim 1 wherein: said body portionsubstantially defines a body portion plane; said plurality of headportions substantially define a plurality of head portion planes; andthe elevation angle formed between said body portion plane and each ofsaid plurality of head portion planes ranges between 10 and 30 degrees.17. An atraumatic bone screw for use in conjunction with a fracturefixation plate comprising: an elongated shaft having a middle section, aproximal end and a distal end; a head portion at said proximal end ofsaid elongated shaft; a smooth rounded bone engaging end at said distalend of said elongated shaft; an external thread on said head portionadapted to engage a threaded hole on said fracture fixation plate; andan external thread on at least a portion of said middle section of saidelongated shaft, said thread adapted to engage a bone.
 18. Theatraumatic bone screw of claim 17 wherein said smooth rounded boneengaging end comprises a half-sphere.
 19. A hook plate for use inconjunction with a fracture fixation plate comprising: a substantiallyrigid plate having a first portion and a second portion; the firstportion adapted for engagement with said fracture fixation plate; thesecond portion configured to wrap around the edge of said fracturefixation plate to engage a bone fragment; the first portion beingsubstantially flat and defining a first portion plane; the secondportion having at least two projections which curve below the firstportion plane and terminate in hook ends adapted to engage said bonefragment; the first portion including a slot for attachment of said hookplate to said fracture fixation plate with a fastener; and the firstportion including a tensioning tab to manipulate said hook plate withrespect to said fracture fixation plate prior to fastening. saidtensioning tab being removable.
 20. A fracture fixation plate kitcomprising: a substantially rigid plate including an elongated bodyportion having proximal and distal ends; said plate including a bonecontacting surface and an opposite surface said plate including aplurality of head portions independently connected to the distal end ofsaid body portion by a corresponding plurality of neck portions; each ofsaid head portions including a plurality of threaded holes adapted toreceive bone fasteners; each of said threaded holes defining a bonefastener axis; said body portion including at least one anchoring hole;said kit further comprising one or more accessories selected from thegroup consisting of: an atraumatic bone screw, a cannulated variableangle fastener, a hook plate, a head drill guide, a K-wire aiming guide,a body drill guide, a plate bender and a plate holder